Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT)
This study has been completed.
Sponsor:
Collaborators:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00032890
First received: April 5, 2002
Last updated: January 20, 2009
Last verified: November 2006
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This study will determine whether glucosamine, chondroitin sulfate and/or the combination of glucosamine and chondroitin sulfate are more effective than placebo and whether the combination is more effective than glucosamine or chondroitin sulfate alone in the treatment of knee pain associated with osteoarthritis (OA) of the knee after six months of follow-up. These substances, marketed in the United States as dietary supplements, have been widely touted by the lay press and by anecdotal personal experience as effective in treating OA. To date, however, only a few small studies have been published in the worldwide literature. The study proposed herein has been carefully constructed to definitively determine the efficacy of these agents.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis |
Drug: glucosamine Drug: chondroitin sulfate Drug: glucosamine and chondroitin sulfate combined Drug: celecoxib |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT) |
Resource links provided by NLM:
MedlinePlus related topics:
Osteoarthritis
Drug Information available for:
Glucosamine hydrochloride
Glucosamine
Sulfate ion
Glucosamine sulfate
Celecoxib
U.S. FDA Resources
Further study details as provided by Department of Veterans Affairs:
| Estimated Enrollment: | 1588 |
| Study Start Date: | April 2000 |
| Estimated Study Completion Date: | February 2004 |
Show Detailed Description Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
40 years and above, both genders, who have clinical and radiographic osteoarthritis symptomatic for at least six months.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00032890
Locations
| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294-7201 | |
| United States, Arizona | |
| *University of Arizona Arthritis Center | |
| Tucson, Arizona, United States, 85724 | |
| United States, California | |
| *Cedars-Sinai Medical Center | |
| Los Angeles, California, United States, 90048 | |
| *University of California, Los Angeles | |
| Los Angeles, California, United States, 90095 | |
| *University of California San Francisco | |
| San Francisco, California, United States, 94110 | |
| United States, Illinois | |
| Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| United States, Indiana | |
| *Indiana University School of Medicine | |
| Indianapolis, Indiana, United States, 46202-5103 | |
| United States, Kansas | |
| *Arthritis Research and Clinical Centers | |
| Wichita, Kansas, United States, 67214 | |
| United States, Nebraska | |
| University of Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68198-3025 | |
| United States, New York | |
| Hospital for Joint Diseases | |
| New York, New York, United States, 10003 | |
| United States, Ohio | |
| *Case Western Reserve University | |
| Beachwood, Ohio, United States, 44122 | |
| United States, Pennsylvania | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| *University of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Texas | |
| Arthritis Consultation Center | |
| Dallas, Texas, United States, 75231-4496 | |
| United States, Utah | |
| *University of Utah | |
| Salt Lake City, Utah, United States, 84132 | |
| United States, Washington | |
| Virginia Mason Research Center | |
| Seattle, Washington, United States, 98101 | |
Sponsors and Collaborators
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00032890 History of Changes |
| Obsolete Identifiers: | NCT00010790 |
| Other Study ID Numbers: | GAIT |
| Study First Received: | April 5, 2002 |
| Last Updated: | January 20, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Department of Veterans Affairs:
|
osteoarthritis knee pain |
Additional relevant MeSH terms:
|
Arthritis Osteoarthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Celecoxib Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Therapeutic Uses Central Nervous System Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 19, 2013